K201122 is an FDA 510(k) clearance for the Canon non-mydriatic retinal camera CR series. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Canon, Inc. (Nakahara-Ku, Kawasaki, JP). The FDA issued a Cleared decision on July 23, 2020, 87 days after receiving the submission on April 27, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K201122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2020 |
| Decision Date | July 23, 2020 |
| Days to Decision | 87 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI — Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |